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From Medical Design & Outsourcing

• Choosing the Right Rubber Material and Process for Your Medical Parts
  When it’s time to design and develop a new medical device that calls for an elastomer component, there are a number of material options and manufacturing processes to consider. The long list of material properties impacting performance includes your prospective polymer’s end-use environment, chemical compatibility, hardness, compression set, tensile properties and manufacturability — to name… […]
• 3M’s healthcare segment registers growth in Street-beating Q2
  3M (NYSE:MMM) reported second-quarter results that beat the consensus forecast — with the company’s healthcare segment showing especially robust growth. The St. Paul, Minn.–based company posted profits of $1.5 billion, or $2.59 per share, on sales of $9 billion for the three months ended June 30, 2021, for a 16.7% bottom-line gain on sales growth of… […]
• Evren Technologies earbud PTSD treatment device nabs FDA breakthrough device designation
  Evren Technologies this week announced that it received FDA breakthrough device designation for its Phoenix earbud device that treats PTSD. Gainesville, Fla.-based Evren Technologies designed the Phoenix device as a discreet earbud design that delivers transcutaneous auricular vagal nerve stimulation in a closed-loop system. It can be paired with the company’s PTSD symptom tracking app… […]
• BD acquires resorbable polymer maker Tepha
  BD (NYSE:BDX) today announced that it has acquired resorbable polymer technology maker Tepha for an undisclosed amount. Franklin Lakes, N.J.–based BD said that it will use Lexington, Mass.–based Tepha’s resorbable polymer technology to accelerate growth of the company’s surgical mesh for soft tissue repair, reconstruction and regeneration. Tepha’s GalaFlex portfolio is also included in the acquisition.… […]
• LifeSignals remote patient monitor wins FDA clearance
  LifeSignals today announced that it has received FDA 510(k) clearance for its LX1550 multi-parameter remote monitoring platform. Fremont, Calif.–based LifeSignals designed the LX1550 to continuously collect patient physiological data from home and in healthcare settings. The platform has a single-use wearable multi-parameter biosensor that records electrocardiography (ECG), heart rate, respiration rate, skin temperature and body… […]
• Blackrock Neurotech and ClearPoint Neuro want to automate brain implant surgeries
  ClearPoint Neuro (NSDQ:CLPT) announced an agreement with Blackrock Neurotech to develop automated technologies for brain implant surgeries. The partnership will seek to develop an automated surgical solution for implanting brain-computer interfaces (BCIs) into patients with neurological disorders — including from paralysis, ALS, blindness and hearing loss. Solana Beach, Calif.–based ClearPoint Neuro said in a news… […]
• New Mountain Capital to acquire Flexan
  New Mountain Capital’s ILC Dover today announced that it has reached a definitive agreement to acquire Flexan for an undisclosed amount. Lincolnshire, Ill.–based Flexan is a contract design and manufacturing company specializing in high-precision silicone, rubber and thermoplastic components for the medical device industry. The acquisition will allow both companies to serve a broader client… […]
• How COVID-19 changed medical device clinical trials forever
  The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials. DeviceTalks Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on… […]
• Nuvasive launches ALIF 3D printed porous titanium implant
  Nuvasive this week announced that it has launched its Modulus ALIF 3D printed porous titanium implant for anterior lumbar interbody fusion. San Diego-based Nuvasive designed Modulus for enhanced osseointegration, according to the company. It has a porous surface architecture engineered for fusion and promotes new bone on-growth and in-growth. The design also allows for enhanced… […]
• Cardinal Health subsidiary faces federal lawsuit over EtO plant in Georgia
  Nearly two dozen people who have lived in the Augusta, Ga. area are suing Cardinal Health subsidiary Kendall Patient Recovery U.S. over ethylene oxide emissions from a medical device sterilization plant in the city. The people suing KPR U.S. in U.S. District Court in Southern Georgia lived and worked within miles of the Augusta facility… […]
• FDA seeks expanded authority to boost medical device supply chain
  The FDA announced as part of its annual budget proposal that it will include $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP). Funding from the RSCSPP for the Center for Devices and Radiological Health (CDRH) will provide — the FDA says, for the first time — resources to establish a… […]